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Active, not recruitingNCT07741370Updated Aug 5, 2026

Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases

An observational study in Lens Diseases, Cataract and Age-related Cataract, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study summary

This multicenter retrospective study will collect clinical data to investigate the associations between preoperative and intraoperative anterior segment structural changes and postoperative surgical outcomes in patients with lens disorders, and to evaluate the clinical benefits of intraoperative optical coherence tomography (iOCT) in lens surgery, with the aim of improving the diagnosis and treatment of lens-related diseases.

Read the detailed description

Lens disorders, particularly cataract, are a leading cause of blindness worldwide and substantially impair quality of life. Surgery remains the most effective treatment, but pre-existing abnormalities of the lens and adjacent ocular structures, together with unexpected intraoperative events, may increase surgical complexity and affect outcomes. Accurate assessment of anterior segment structures is therefore essential, as abnormalities caused by trauma, congenital disorders, ocular diseases, or systemic conditions may involve the lens, capsule, cornea, iris, or anterior chamber angle. Even during routine phacoemulsification, variations in irrigation pressure, anterior chamber depth, capsular bag integrity, capsular expansion, and residual cortex may influence surgical safety, IOL centration, and postoperative refractive stability. Because some abnormalities cannot be reliably detected preoperatively, intraoperative optical coherence tomography (iOCT) may provide real-time structural information and support surgical decision-making. However, evidence regarding its effects on surgical strategy, visual outcomes, refractive stability, and complications remains limited. This multicenter retrospective study will assess the associations between preoperative and intraoperative anterior segment changes and postoperative outcomes, and evaluate the clinical value of iOCT in lens surgery.

02

Conditions studied

  • Lens Diseases
  • Cataract
  • Age-related Cataract
  • Complicated Cataract
  • Lens Subluxation

Keywords

  • Intraoperative Optical Coherence Tomography
  • Lens Diseases
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients aged 18 years or older who underwent lens surgery for lens opacity or abnormal lens position between March 1, 2024 and March 1, 2026 at the participating hospitals. Eligible surgical eyes will be identified retrospectively from medical records and classified according to whether intraoperative optical coherence tomography was used during surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or older.
  • Presence of lens opacity or abnormal lens position.
  • Visual impairment affecting activities of daily living.
  • Met the indications for lens surgery.
  • Underwent lens surgery.

Exclusion criteria

Exclusion Criteria:

  • Active intraocular inflammation.
  • Uncontrolled systemic disease, use of medications that could significantly affect surgery, or other standard to lens surgery.
  • Incomplete or unreliable key preoperative examination data, including ocular biometry.
  • Inadequate image quality due to poor fixation or other causes, rendering the images unsuitable for analysis.
  • Incomplete intraoperative OCT recordings, such as interrupted recording or severe image freezing, affecting data evaluation.
  • Other psychological or physical conditions that might interfere with study participation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Conventional Microscopy Cohort

    Patients who underwent lens surgery using conventional surgical microscopy without intraoperative OCT.

  • Intraoperative OCT-Assisted Surgery Cohort

    Patients who underwent lens surgery using conventional surgical microscopy with intraoperative OCT assistance.

    Device: Intraoperative Optical Coherence Tomography

Interventions

  • DeviceIntraoperative Optical Coherence Tomography

    Intraoperative optical coherence tomography technique can provide intraocular images and show changes in intraocular structures, assisting in analyzing the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases.

06

What researchers measure

Primary outcomes

  1. Concordance Rate Between Preoperative and Intraoperative Diagnoses

    Preoperative diagnoses are determined based on routine ophthalmic examinations. Intraoperative diagnoses are determined based on surgical microscopic observations, intraoperative OCT images, and operative records. Concordance between the preoperative and intraoperative diagnoses is assessed, including whether the intraoperative diagnosis adds to or corrects the preoperative diagnosis.

    Time frame: From completion of the preoperative examinations through the end of surgery; diagnostic concordance is assessed after surgery.

Secondary outcomes

  1. Intraocular Lens Tilt Angle

    The tilt angle of the implanted intraocular lens is measured on intraoperative OCT images using a standardized image analysis protocol. A predefined ocular-axis reference line is used to calculate the angle between the intraocular lens axis and the reference axis.

    Time frame: After intraocular lens implantation and at the end of surgery.

  2. Incidence of Intraoperative Complications

    Intraoperative complications are identified from operative records and intraoperative imaging. The incidence of each complication is calculated.

    Time frame: From the start to the end of surgery.

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07741370
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators
Chinese PLA General Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Fourth Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, People's Hospital of Ningxia Hui Autonomous Region
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Mar 1, 2024
Primary completion
Mar 1, 2026
Completion
Dec 31, 2034 (estimated)
Last update
Aug 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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